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FANAPT

Iloperidone · Tablet

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
FANAPT
Generic name
Iloperidone
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Vanda Pharmaceuticals Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
7
NDC product codes
11
Packages
11
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Iloperidone 1 mg/1 848722 View
Iloperidone 10 mg/1 848722 View
Iloperidone 12 mg/1 848722 View
Iloperidone 2 mg/1 848722 View
Iloperidone 4 mg/1 848722 View
Iloperidone 6 mg/1 848722 View
Iloperidone 8 mg/1 848722 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
22

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Atypical Antipsychotic [EPC] EPC All 62 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022192
Application type
NDA · New Drug Application
Approval date
May 6, 2009
Sponsor
VANDA PHARMS INC
Products on application
7
Submissions recorded
21
Products approved under application 022192.
Product Trade name Form Strength Ingredient Status TE Flags
022192-001 FANAPT TABLET ILOPERIDONE Prescription AB RLD RS
022192-002 FANAPT TABLET ILOPERIDONE Prescription AB RLD
022192-003 FANAPT TABLET ILOPERIDONE Prescription AB RLD
022192-004 FANAPT TABLET ILOPERIDONE Prescription AB RLD
022192-005 FANAPT TABLET ILOPERIDONE Prescription AB RLD
022192-006 FANAPT TABLET ILOPERIDONE Prescription AB RLD
022192-007 FANAPT TABLET ILOPERIDONE Prescription AB RLD

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8586610 November 2, 2027 001 No U-1625 January 8, 2015
8586610 November 2, 2027 002 No U-1625 January 8, 2015
8586610 November 2, 2027 003 No U-1625 January 8, 2015
8586610 November 2, 2027 004 No U-1625 January 8, 2015
8586610 November 2, 2027 005 No U-1625 January 8, 2015
8586610 November 2, 2027 006 No U-1625 January 8, 2015
8586610 November 2, 2027 007 No U-1625 January 8, 2015
10570453 March 28, 2028 001 No U-4562 July 9, 2026
10570453 March 28, 2028 001 No U-4563 July 9, 2026
10570453 March 28, 2028 002 No U-4562 July 9, 2026
10570453 March 28, 2028 002 No U-4563 July 9, 2026
10570453 March 28, 2028 003 No U-4562 July 9, 2026
10570453 March 28, 2028 003 No U-4563 July 9, 2026
10570453 March 28, 2028 004 No U-4562 July 9, 2026
10570453 March 28, 2028 004 No U-4563 July 9, 2026
10570453 March 28, 2028 005 No U-4562 July 9, 2026
10570453 March 28, 2028 005 No U-4563 July 9, 2026
10570453 March 28, 2028 006 No U-4562 July 9, 2026
10570453 March 28, 2028 006 No U-4563 July 9, 2026
10570453 March 28, 2028 007 No U-4562 July 9, 2026
10570453 March 28, 2028 007 No U-4563 July 9, 2026
9157121 April 5, 2030 001 No U-1674 October 13, 2015
9157121 April 5, 2030 002 No U-1674 October 13, 2015
9157121 April 5, 2030 003 No U-1674 October 13, 2015
9157121 April 5, 2030 004 No U-1674 October 13, 2015
9157121 April 5, 2030 005 No U-1674 October 13, 2015
9157121 April 5, 2030 006 No U-1674 October 13, 2015
9157121 April 5, 2030 007 No U-1674 October 13, 2015
10563259 July 24, 2030 001 No U-4562 July 9, 2026
10563259 July 24, 2030 001 No U-4563 July 9, 2026
10563259 July 24, 2030 002 No U-4562 July 9, 2026
10563259 July 24, 2030 002 No U-4563 July 9, 2026
10563259 July 24, 2030 003 No U-4562 July 9, 2026
10563259 July 24, 2030 003 No U-4563 July 9, 2026
10563259 July 24, 2030 004 No U-4562 July 9, 2026
10563259 July 24, 2030 004 No U-4563 July 9, 2026
10563259 July 24, 2030 005 No U-4562 July 9, 2026
10563259 July 24, 2030 005 No U-4563 July 9, 2026
10563259 July 24, 2030 006 No U-4562 July 9, 2026
10563259 July 24, 2030 006 No U-4563 July 9, 2026
10563259 July 24, 2030 007 No U-4562 July 9, 2026
10563259 July 24, 2030 007 No U-4563 July 9, 2026
8652776 August 31, 2030 001 No U-1685 April 30, 2015
8652776 August 31, 2030 002 No U-1685 April 30, 2015
8652776 August 31, 2030 003 No U-1685 April 30, 2015
8652776 August 31, 2030 004 No U-1685 April 30, 2015
8652776 August 31, 2030 005 No U-1685 April 30, 2015
8652776 August 31, 2030 006 No U-1685 April 30, 2015
8652776 August 31, 2030 007 No U-1685 April 30, 2015
12606869 September 22, 2030 001 No U-4504 May 21, 2026
12606869 September 22, 2030 001 No U-4505 May 21, 2026
12606869 September 22, 2030 002 No U-4504 May 21, 2026
12606869 September 22, 2030 002 No U-4505 May 21, 2026
12606869 September 22, 2030 003 No U-4504 May 21, 2026
12606869 September 22, 2030 003 No U-4505 May 21, 2026
12606869 September 22, 2030 004 No U-4504 May 21, 2026
12606869 September 22, 2030 004 No U-4505 May 21, 2026
12606869 September 22, 2030 005 No U-4504 May 21, 2026
12606869 September 22, 2030 005 No U-4505 May 21, 2026
12606869 September 22, 2030 006 No U-4504 May 21, 2026
12606869 September 22, 2030 006 No U-4505 May 21, 2026
12606869 September 22, 2030 007 No U-4504 May 21, 2026
12606869 September 22, 2030 007 No U-4505 May 21, 2026
8999638 October 28, 2030 001 No U-1674 April 7, 2015
8999638 October 28, 2030 002 No U-1674 April 7, 2015
8999638 October 28, 2030 003 No U-1674 April 7, 2015
8999638 October 28, 2030 004 No U-1674 April 7, 2015
8999638 October 28, 2030 005 No U-1674 April 7, 2015
8999638 October 28, 2030 006 No U-1674 April 7, 2015
8999638 October 28, 2030 007 No U-1674 April 7, 2015
9074255 December 17, 2030 001 No U-1674 July 28, 2015
9074255 December 17, 2030 002 No U-1674 July 28, 2015
9074255 December 17, 2030 003 No U-1674 July 28, 2015
9074255 December 17, 2030 004 No U-1674 July 28, 2015
9074255 December 17, 2030 005 No U-1674 July 28, 2015
9074255 December 17, 2030 006 No U-1674 July 28, 2015
9074255 December 17, 2030 007 No U-1674 July 28, 2015
9072742 January 16, 2031 001 No U-1674 July 28, 2015
9072742 January 16, 2031 002 No U-1674 July 28, 2015
9072742 January 16, 2031 003 No U-1674 July 28, 2015
9072742 January 16, 2031 004 No U-1674 July 28, 2015
9072742 January 16, 2031 005 No U-1674 July 28, 2015
9072742 January 16, 2031 006 No U-1674 July 28, 2015
9072742 January 16, 2031 007 No U-1674 July 28, 2015
9074256 February 10, 2031 001 No U-1674 July 28, 2015
9074256 February 10, 2031 002 No U-1674 July 28, 2015
9074256 February 10, 2031 003 No U-1674 July 28, 2015
9074256 February 10, 2031 004 No U-1674 July 28, 2015
9074256 February 10, 2031 005 No U-1674 July 28, 2015
9074256 February 10, 2031 006 No U-1674 July 28, 2015
9074256 February 10, 2031 007 No U-1674 July 28, 2015
9074254 December 28, 2031 001 No U-1674 July 28, 2015
9074254 December 28, 2031 002 No U-1674 July 28, 2015
9074254 December 28, 2031 003 No U-1674 July 28, 2015
9074254 December 28, 2031 004 No U-1674 July 28, 2015
9074254 December 28, 2031 005 No U-1674 July 28, 2015
9074254 December 28, 2031 006 No U-1674 July 28, 2015
9074254 December 28, 2031 007 No U-1674 July 28, 2015
Regulatory exclusivity periods.
Code Expires Product
I-939 April 2, 2027 001
I-939 April 2, 2027 002
I-939 April 2, 2027 003
I-939 April 2, 2027 004
I-939 April 2, 2027 005
I-939 April 2, 2027 006
I-939 April 2, 2027 007

Approval history

Source: Drugs@FDA
Most recent submissions on application 022192.
Type No. Action Status Date Review
Supplement 24 Labeling Approved January 22, 2025 Standard
Supplement 23 Efficacy Approved April 2, 2024 Standard
Supplement 21 Labeling Approved February 23, 2017 901 Required
Supplement 18 Labeling Approved February 23, 2017 Standard
Supplement 20 Manufacturing (CMC) Approved January 6, 2017 Standard
Supplement 15 Efficacy Approved May 26, 2016 Standard
Supplement 16 Manufacturing (CMC) Approved March 29, 2016 —
Supplement 17 Labeling Approved January 5, 2016 901 Required
Supplement 14 Manufacturing (CMC) Approved March 30, 2015 —
Supplement 13 Labeling Approved April 21, 2014 Standard
Supplement 12 Manufacturing (CMC) Approved July 19, 2013 —
Supplement 10 Manufacturing (CMC) Approved July 12, 2013 —
Supplement 11 Manufacturing (CMC) Approved May 30, 2013 —
Supplement 7 Labeling Approved January 31, 2013 Standard
Supplement 9 Labeling Approved January 27, 2012 Standard
Supplement 6 Labeling Approved September 7, 2011 Standard
Supplement 5 Labeling Approved September 7, 2011 Standard
Supplement 4 Labeling Approved March 21, 2011 Unknown
Supplement 2 Labeling Approved December 1, 2010 901 Required
Supplement 1 Labeling Approved August 24, 2010 Unknown
Original application 1 Type 1 - New Molecular Entity Approved May 6, 2009 Standard

Review documents

  • 0 · Supplement · February 6, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Supplement · April 18, 2024
  • 0 · Supplement · April 3, 2024
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · March 2, 2017
  • 0 · Supplement · February 24, 2017
  • 0 · Supplement · February 24, 2017
  • 0 · Supplement · June 1, 2016
  • 0 · Supplement · May 27, 2016
  • 0 · Supplement · January 6, 2016
  • 0 · Supplement · January 6, 2016
  • 0 · Supplement · April 22, 2014
  • 0 · Supplement · April 22, 2014
  • 0 · Supplement · February 4, 2013
  • 0 · Supplement · February 1, 2013
  • 0 · Supplement · January 31, 2012
  • 0 · Supplement · January 30, 2012
  • 0 · Original application · December 22, 2011
  • 0 · Supplement · September 12, 2011
  • 0 · Supplement · September 12, 2011
  • 0 · Supplement · September 12, 2011
  • 0 · Supplement · September 12, 2011
  • 0 · Supplement · March 28, 2011
  • 0 · Supplement · March 24, 2011
  • 0 · Supplement · December 6, 2010
  • 0 · Supplement · December 4, 2010
  • 0 · Supplement · August 27, 2010
  • 0 · Supplement · August 26, 2010
  • 0 · Original application · June 12, 2009

Adverse event reports

Source: openFDA FAERS
1,470
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ILOPERIDONE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
43068-101-02 43068-101 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-101-02) May 1, 2016
43068-102-02 43068-102 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-102-02) August 1, 2016
43068-104-02 43068-104 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-104-02) December 15, 2015
43068-106-02 43068-106 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-106-02) July 1, 2016
43068-108-02 43068-108 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-108-02) September 15, 2015
43068-110-02 43068-110 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-110-02) January 15, 2016
43068-112-02 43068-112 Vanda Pharmaceuticals Inc. 60 TABLET in 1 BOTTLE (43068-112-02) October 15, 2016
43068-901-14 43068-901 Vanda Pharmaceuticals Inc. 14 TABLET in 1 BOTTLE (43068-901-14) September 24, 2018
43068-902-14 43068-902 Vanda Pharmaceuticals Inc. 14 TABLET in 1 BOTTLE (43068-902-14) September 24, 2018
43068-904-14 43068-904 Vanda Pharmaceuticals Inc. 14 TABLET in 1 BOTTLE (43068-904-14) June 11, 2024
43068-905-14 43068-905 Vanda Pharmaceuticals Inc. 14 TABLET in 1 BOTTLE (43068-905-14) June 11, 2024
43068-101 43068-101 Vanda Pharmaceuticals Inc. — May 1, 2016
43068-102 43068-102 Vanda Pharmaceuticals Inc. — August 1, 2016
43068-104 43068-104 Vanda Pharmaceuticals Inc. — December 15, 2015
43068-106 43068-106 Vanda Pharmaceuticals Inc. — July 1, 2016
43068-108 43068-108 Vanda Pharmaceuticals Inc. — September 15, 2015
43068-110 43068-110 Vanda Pharmaceuticals Inc. — January 15, 2016
43068-112 43068-112 Vanda Pharmaceuticals Inc. — October 15, 2016
43068-901 43068-901 Vanda Pharmaceuticals Inc. — September 24, 2018
43068-902 43068-902 Vanda Pharmaceuticals Inc. — September 24, 2018
43068-904 43068-904 Vanda Pharmaceuticals Inc. — June 11, 2024
43068-905 43068-905 Vanda Pharmaceuticals Inc. — June 11, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.